Evaluation of the Efficacy and Safety of Nise 100 mg in the Management of Osteoarthrosis (Gonarthrosis)

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Study is conducted to evaluate safety and efficacy in patients with osteoarthritis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Nimesulide

Criteria

Inclusion Criteria:

• patients 40 years old and older with verified diagnosis of OA of the knee joints according to the criteria of American College of Rheumatology (АСR);

• radiologic abnormalities complying with I-III grades of Kellgren;

• pain syndrome not less than 40 points according to 100-point visual analogue scale (VAS).

Exclusion Criteria:

• A history of the patient within the last 5 years malignancy of any organ or system regardless of whether the treatment and is carried on this occasion elk.

• The presence of acute ulcer disease of the gastrointestinal tract that is, over several recent years.

• Any data on the bleeding from the upper gastrointestinal tract.

• Severe disease: uncontrolled hypertension, expression n naya cardiovascular failure, a pathology of the hematopoietic system, and mellitus type I, and others.

• The presence of other rheumatic diseases with the exception of teoartroza.

• Liver disease (cirrhosis, chronic hepatitis).

• Abnormal liver function (ALT, AST, bilirubin more than 1.5 times the upper limit of normal).

• Impaired renal function (blood creatinine more than 1.5 times higher than it's ver limit of normal).

• Anemia (g emoglobin more than 10 g / l less than the lower limit of normal).

• Treatment with corticosteroids (systemic reception), warfarin and other coumarin governmental produ d.

• Hypersensitivity to the analgesic and antipyretic Wed d stvam, NSAIDs, sulfonamides.

• Pregnancy and lactation.

• Alcohol and drug abuse history.